Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-11-06
2001-07-17
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C128S899000, C324S260000
Reexamination Certificate
active
06263230
ABSTRACT:
TECHNICAL FIELD
This invention is generally directed to a system and method for detecting the location of an indwelling medical device within the body of a patient and, more specifically, to a detection apparatus which senses magnetic field strength generated by a magnet associated with the indwelling medical device.
BACKGROUND OF THE INVENTION
There are many instances in clinical medicine where detecting the location of a medical tube within a patient is important. For example, when positioning feeding tubes through the mouth or nose of a patient, it is essential that the end of the feeding tube pass into the patient's stomach, and that it does not “curl up” and remain in the esophagus. If the end of the feeding tube is not properly positioned within the stomach, aspiration of the feeding solution into the patient's lungs may occur. In addition to feeding tubes, a variety of other medical tubes require accurate positioning within a patient's body, including dilating tubes to widen an esophageal stricture, tubes for measuring pressure waves in the stomach and esophagus of a patient who is suspected of having esophageal motor disorders, Sengstaken-Blakemore tubes in the stomach and esophagus of a patient to control bleeding from varicose veins in the esophagus, colonic decompression tubes in the colon of a patient to assist in relieving distention of the colon by gas, urologic tubes in the bladder, ureter or kidney of a patient, laser tubes inserted into the heart for transmyocardial revascularization, and vascular tubes in the heart or pulmonary arteries of a patient.
Currently, the location of a medical tube within the body of a patient is routinely detected by the use of imaging equipment, such as a chest or abdominal X-ray. However, such a procedure requires transportation of the patient to an X-ray facility or, conversely, transportation of the X-ray equipment to the patient. This is both inconvenient and costly to the patient, and is particularly stressful in those instances where the patient repeatedly and inadvertently removes a medical tube, such as a feeding tube, thus requiring repeated reinsertion and X-rays.
Prior attempts at detecting the location of medical tubes within a patient have met with only limited success. For example, in U.S. Pat. No. 5,099,845 to Besz et al., a transmitter is located within a catheter, and an external receiver, tuned to the frequency of the transmitter, is used to detect the location of the catheter within the patient. This approach, however, requires either an external or internal power source to drive the transmitter. An external power source adds significant risk associated with shock or electrocution, and requires that electrical connections be made prior to positioning of the catheter within the patient. An internal power source, such as a battery, must be relatively small and can only provide power to the transmitter for a limited time. This precludes long-term detection of the catheter's location, and poses additional risks associated with placing a battery internally in a patient, such as the risk of battery leakage or rupture. In addition, the transmitter is relatively complex, and requires an active electronic circuit (either internal or external to the catheter), as well as the various wires and connections necessary for its proper function. Lastly, the signal produced by the transmitter is attenuated differently by different body tissues and bone. This attenuation requires adjustments in the transmitter's signal strength and frequency depending on the location of the catheter within the patient's body.
A further attempt at detecting the location of medical tubes within a patient is disclosed in U.S. Pat. No. 4,809,713 to Grayzel. There, an electrical cardiac-pacing catheter is held in place against the inner heart wall of a patient by the attraction between a small magnet located in the tip of the pacing catheter and a large magnet located on (e.g., sewn into) the patient's chest wall. An indexed, gimbaled, three-dimensional compass is used to determine the best location for the large magnet. The compass' operation relies upon the torque generated by the magnetic forces between the small magnet and the magnetized compass pointer in order to point the compass towards the small magnet. However, this compass will simultaneously try to orient itself to the Earth's ambient magnetic field. Because of this, the forces between the small magnet and the magnetized compass pointer at distances greater than several centimeters are not strong enough to accurately orient the compass towards the small magnet. Furthermore, although the compass aids positioning of the large magnet, positioning of the small magnet, and hence the pacing catheter, still requires the use of imaging equipment, such as X-ray or ultrasound.
For the foregoing reasons, there is a need in the art for a medical tube, apparatus and method for detecting the location of the medical tube within the body of a patient which avoids the problems inherent in existing techniques. The medical tube, apparatus and method should provide for the detection of the medical tube at distances ranging from several centimeters to several decimeters, should not require the medical tube to have an internal or external power source, and should obviate the need to independently verify positioning of the medical tube with imaging equipment.
SUMMARY OF THE INVENTION
The present invention is embodied in the a system and method for the detection of a plurality of magnets within the patient from a measurement location on the surface of the patient. The system comprises a plurality of magnetic sensors, each of which is oriented in a known direction and generates a set of signals as a function of the static magnetic field strength and direction due to each of the plurality of magnets. A processor calculates an estimated position of each of the plurality of magnets in a three-dimensional space and calculates values related to a predicted magnetic field strength through at least a portion of the sensors based on the estimated positions of the plurality of magnets. The processor also calculates values related to an actual magnetic field strength using the set of signals from the magnetic sensors and determines values related to the location of each of the plurality of magnets based on a difference between the values related to the predicted magnetic field strength and the values related to the actual magnetic field strength. A display is provided to display the values related to the position of each of the plurality of magnets is the three-dimensional space.
In one embodiment, the estimated position may be calculated using signals from selected ones of the plurality of magnetic sensors whose signals are above a predetermined threshold. Although the sensors can be configured in any position and orientation with respect to each other, calculations may be conveniently performed by orienting the sensors in an array, with sensors oriented along orthogonal axes to provide measurement capability along the orthogonal axes.
The position and orientation of the indwelling medical device and associated magnet may be characterized by 5° of freedom indicating the location in three-dimensional space and the angular orientation in two planes. Each magnet may be similarly characterized by the same number of parameters. In an exemplary embodiment, the system provides a number of sensors that at least is equal to the number of parameters required to characterize the plurality of magnets. In a preferred embodiment, the system also includes additional magnetic sensors to provide compensation for the effects of the Earth's magnetic field.
In another embodiment, a single indwelling medical device may have two magnets associated therewith. The associated magnets have axes of magnetization which are not aligned with each other. The processor calculates a rotation of the indwelling medical device based on values related to the positions of the first and second magnets into three
Golden Robert N.
Haynor David R.
Sanders Gary B.
Somogyi Christopher P.
Donohue Michael J.
Lateef Marvin M.
Lucent Medical Systems, Inc.
Seed IP Law Group PLLC
Shaw Shawna J
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